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Assessment Tool For Licensing A General Clinical Lab New Ao
Assessment Tool For Licensing A General Clinical Lab New Ao
2021-_(pH37
ANNEX B1
Republic of the Philippines
Department of Health
HEALTH FACILITIES AND SERVICES REGULATORY BUREAU
. Make sure to fill-in the blanks with the needed information. Do not leave any items blank. Put N/A if Not
Applicable.
. The Team Leader shall ensure that all team members write down their printed names, designation and affix
DO
their signatures and indicate the date of inspection/monitoring, all at the last page of the tod.
. The Team Leader shall make sure that the Head of the facility or, when not available, the next most senior or
responsible officer likewise affix his/her signature on the same aforementioned pages, to signify that the
inspection/monitoring results were discussed during the exit conference and a duplicate copy received. also
GENERAL INFORMATION:
Name of Facility:
Complete Address:
Number& Street
Barangay/District
Municipality/City Province/Region
Existing License
Number: Date Issued:
. ;
Expiry Date:.
7
Service Capability 0 Primary
Laboratory
Secondary O Limited-Service Capability
DOH-HFSRB-QOP01-CLG-AT
Revision: 00
05/11 2021
Page 10f 13
Fe
F
i
Lb
bE
CRITERIA
cof
A)
supplies, etc.
DOH-HFSRB-QOP01-CLG-AT
Revision: 00
14/2021
Page 2 of 13
t
CRITERIA’ Fo COMPLIED|
5. There is policy Document Review
and procedure ¢ Written policy and procedure
for handling for handling complaints/client
complaints and feedback
client feedback ¢ Suggestion box visible to
clients
e Forms for complaints/ client
feedback
¢ Records of complaints/ client
feedback and actions taken
ll. HUMAN RESOURCE MANAGEMENT
A. STAFF RECRUITMENT, SELECTION, APPOINTMENT AND RESPONSIBILITIES
6. There is policy Document Review
and procedure o Written policies and
for hiring, procedures on hiring,
orientation and orientation and promotion of
promotion for all personnel at all levels
levels of
personnel
7. There is policy Document Review
and procedure * Written policies and
on continuing procedures for staff
program for staff development and training
development ¢ Proof of training through
and training relevant certificates, memos,
written reports, budgetary
allocations
Interview
« Human Resources
Management Officer/
Personnel Officer
8. There is policy Document Review
and procedure + Written policies and procedures
for discipline, on discipline, suspension,
suspension, demotion and termination of
demotion and personnel at all levels
termination of
personnel at all
levels
B. PERSONNEL
9. The duties and Document Review
responsibilities * Written job description or duties
shall be clearly and responsibilities of all
stated laboratory personnel
10. Thereis an Document Review
adequate eo List of Personnel with
number of designation
qualified * Area of assignments indicated
personnel with in the posted work schedule
documented
DOH-HFSRB-QCP01-CLG-AT
Revision: 00
0G/112021
Page 3 of 13
Eo :
© REMARKS.
LT
£
“CRITERIA Je INDICATOR/EVIDENCE COMPLIED
F
« Proof of qualifications
(please refer to specific
personnel)
Authority to practice signed
+
applicable (A.O. # 92 s.
2003)
11. There is policy on Document Review
the » Proof of submission of datato
implementation NDHRHIS
of National
Database of
Human Resource
for Health
Information
System
(NDHRIS)
12. Each personnel Document Review
shall have a ¢ Updated 201 files of all
record of updated laboratory personnel
201 files
A. The Head of the Document Review
Laboratory o Proof of supervisory visits at
(HOL) shall least once a week for physica
have the overall visit OR once a month physical
supervision on visit with at least twice a week
technical of supervisory calls and/or
procedures as video conferencing
well as on the e For HOL of hospital-based
administrative clinical laboratory: supervisory
laboratory physical visits of at least once a
management week
» Proof of qualifications:
+
Updated resume
+
PRC certificate and valid
PRC ID
+
PSP Board Certificate
+
Certificate of Good Standing
from PSP
+
Notarized employment
contract
DOH-HFSRB-QOP01-CLG-AT
Revision: 00
a6/112021
Page 4 of 13
_|
CRITERIA
Qualification of Head of
A. Clinical
~
| INDICATOR/EVIDENCE
»
«
Relevant training certificates
(e.g., Molecular Pathology)
Annual medical certificate
and proof of immunization
(Hepatitis B and Influenza)
Certified CP
~~
| COMPLIED
Certified AP
~~ REMARKS
Remarks
1. Prim /
2. /
37
4. Limited*
/
B. Anatomic
C. Molecular
1. Genetics**
2. Immunohem
3. Infectious
* It
depend on the limited services to be provided
will
**A pathologist or a licensed physician who is trained in the management, principles and methodology of these
specialized services that are being provided shall head this type of laboratory
EE
[A
i
B.
CRITERIA
Registered
Medical
INDICATOR/EVIDENCE
Document Review
¢ Proof of qualifications:
| COMPLIED T— ~~ "REMARKS
Technologist »
Updated resume
(RMT) * PRC certificate and valid
PRC ID
(At least 1 + Relevant training certificates
competent » Notarized employment
RMT per contract
assigned area) «Annual medical certificate
«Proof of immunization
(Hepatitis B and Influenza)
staff with
.
RMT
designated
assignments, as
os
Additional proof of trainings
applicable:
1. rHIVda
o
ane) of proficiency
2. AFB microscopy| *
TRL of training on DSSM
o Certificate of training in
3. Bacteriology bacteriology (RITM and other
RITM recognized institutions)
¢ Certificate of training in malaria
4)
4. Malaria smear
smear (RITM)
DOH-HF SRB-QOP01-CLG-AT
Revision: 00
Q6/44 2021
Page 50f 13
5. Others
C. Biosafety and Document Review
Biosecurity o PRC certificate and valid PRC
Officer (May be ID (RMT)
designated by o Certificate of training in
the HOL) Biosafety and Biosecurity
(RITM and/or UP-NTCBB)
Hematology 1 1 1 1 1 1 1 1 1
Clinical Chemistry 1 1 1 1 1 1 1
Immunology/Serology 1
1 1
Microbiology 1
1
Histopathology 1
2. Clinical Laboratory for Anatomic Pathology — At least one RMT per section
3. Clinical Laboratory for Molecular Pathology — Will depend on the services offered
"
Observe
» Updated proof of actual
implementation of maintenance
as to structure, ventilation,
lighting & water supply
14. There are policy Document Review
guidelines on ¢ Local risk assessment reviewed
laboratory at least annually
biosafety and ¢ Written protocols on laboratory
biosecurity biosafety and biosecurity
Observe
¢ Good Laboratory Practice that
includes use of Personal
DOH-HF SRB-QOP01-CLG-AT
Revision: 00
06/41/2021
Page 6 of 13
CRITERIA ~
Document Review
and other
Eq uipment
precautionary measures
* Policy on disposal of wastes
that conform with Healthcare
COMPLIED REMARKS
|
disposal of Waste Management Manual,
waste and and RA No. 6969
hazardous/infect + Notarized Memorandum of
ious substances Agreement (MOA) with
that shall infectious waste, toxic, and
conformto the hazardous substances hauler
standards set by
the DOH Observe
¢ Proof of proper management of
wastes from point of generation,
segregation (color-coded waste
bins), disinfection, up to the fina
disposal
NOTE: Please see the reference plan/physical plant (Annex D1 and D2)
IV. EQUIPMENT /INSTRUMENTS
16. There is an Document Review
adequate o List of available and functional
number of laboratory equipment
operational
equipment to Observe
provide the + All laboratory equipment and
laboratory instruments are operational
examinations
that the
laboratory is
licensed for
17. There is Document Review
program for ¢ Regular schedule including
calibration, frequency of preventive
preventive maintenance and calibration
maintenance * Updated certificate of calibration
and repair for and maintenance of equipment
the equipment. ¢ Record of repair reports
18. There is Document Review
contingency plan e« Written policy on contingency
in case of plan in case of equipment
equipment breakdown
breakdown
V. REAGENTS AND SUPPLIES
19. There is an Document Review
adequate supply Quality records of supplies
of properly Ireagents with expiration date,
stored and their usage/ consumption and
inventoried disposal are available
reagents and s Certificate of Product
supplies for the Registration from FDA,
“77 DOH-HFSRB-QOP01-CLG-AT
Revision: 00
06/41/2021
Page 7 of 13
CRITERIA
laboratory —
examinations to
be provided.
| ¢
INDICATOR/EVIDENCE
“including the reagents, supplies,
and equipment used for POCT
and MCL
Observe
Availability and completeness
of reagents and supplies
~|COMPLIED
—
|
~~ REMARKS
—
=~
and maintenance of the
laboratory
A. Communication and Records
24. There are Document Review
procedures forthe] « Documented procedures for
receipt and receipt and performance of
performance of laboratory tests
laboratory tests
25. There are Document Review
procedures for Documented procedures for
eo
DOH-HFSRB-QOP01-CLG-AT
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06/112021
Page 9 of 13
28. There is a Document review
procedure for e¢ Documented procedures for
reporting and reporting and analysis of
analysis of incidents, adverse events, etc.
incidents, e Compiled of written reports with
adverse events, resolutions
and other
related process.
29. There is a Document review
documented e Documented procedure for the
procedure on retention of records which
the retention of follows standards promulgated
documents, by the DOH
records, slides, e Compiled laboratory tests
and specimens results, whether logbook or
of the clinical electronically stored
laboratory which
shall follow
standards
promulgated by
the DOH (DC#
70 s. 1996)
and/or
competent
professional
organizations
B. Quality Assurance
30. There is a policy Document review
on Quality e Documented Internal QAP
Assurance including Internal Quality
Program (QAP) Control and Continuous Quality
and Continuous Improvement
Quality « Updated Quality Control reports
Improvement conducted per tests and filed
accordingly
e Availability of reference
materials and appropriate
reagents & equipment used
¢ Resultsffindings of Quality
Assurance audits / assessments
31. There is a proof Document review
of participation in ¢ Documented procedure in the
External QAP actual performance of EQAP
(EQAP) that may activities
be administered e Certificate of Performance in
by a designated EQAP with passing rate
NRL or other
4
local and
international
EQAP approved
by the DOH
C. Referral or Outsourcing of Laboratory Tests g
DOH-HFSRB-QOP01-CLG-AT
Revision: 00
06/11/2021
Page 10 of 13
32. There is a policy
on referral and
-
Document Review
¢ Documented procedures on
|.
COMPLIED
A
Agreement between the clinical
laboratory and the facility where
the mobile activity is conducted
DOH-HFSRB-QOPO1-CLG-AT
Revision: 00
1 2021
Page 11 of 13
Republic of the Philippines
. Department of Health
HEALTH FACILITIES AND SERVICES REGULATORY BUREAU
Name of Facility:
Date of Inspection:
RECOMMENDATIONS:
For Licensing Process
Issuance depends upon compliance to the recommendations given and submission of the
[1] following within days from the date of inspection.
[1 Non-issuance.
Specify reason/s:
Inspected by:
Printed Name Signature Position/Designation
Received by:
Signature:
Printed Name:
Position/Designation:
Date:
DOH-HF SRB-QOP01-CLG-AT
Revision: 00
Q6/112021
Page 120f 13
Republic of the Philippines
2 Department of Health
>/ HEALTH FACILITIES AND SERVICES REGULATORY BUREAU
Name of Facility:
Date of Monitoring:
RECOMMENDATIONS:
For Monitoring Process
[1 Issuance of Notice of Violation.
[1 Others. Specify:
Monitored by:
Printed Name Signature Position/Designation
Received by:
Signature:
Printed Name:
Position/Designation:
Date:
DOH-HFSRB-QOPO1-CLG-AT
Revision: 00
7142021
Page 130f 13
A.O.No.2021- 0037
Republic of the Philippines ANNEX B2
Department of Health
HEALTH FACILITIES AND SERVICES REGULATORY BUREAU
|
and X if not; or NA for Not Applicable)
___
Spill Kits
aEAR
EQUIPMENT /
SERVICES INSTRUMENT / REAGENTS. ot
GLASSWARE/SUPPLIES
Clinical Microscopy
Supplies
Slides
__ Test tubes (10ml)
___
___
Cover Slips
__ Test Tube
Applicator
Rack
sticks Urine Strips
___
__4- parameter
Manual __
10 - parameter
URINALYSIS __
Clinical Centrifuge (2,000
pm) Control/s
__ Microscope (Binocular Normal
Compound) ___ Pathologic
1
__ Automated
__ Strip Reader
___
Urine Analyzer
DOH-HFSRB-CLG-AT AnnexB2
Revision: 00
06/11/2021
Page 1 of 6
EQUIPMENT /
REAGENT/S REMARKS
SERVICES INSTRUMENT /
GLASSWARE/SUPPLIES Mo <'Exeim (Quality improvement)
PREGNANCY TEST
__ Pregnancy test kit
FECAL OCCULT
___ Occult blood test kit
.
BLOOD
Special Tests: For Indicate the Test
DOH identified
endemic areas
only(e.g., Kato Katz,
Schistosomiasis,
Malaria smear, Filaria
smear, slit-skin
smear, rapid plasma
regain for syphilis)
Hematology
__ Manual __ Hemoglobin
___Spectrophotometer or
its Reagent (Cyanmet
HEMOGLOBIN equivalent Hemoglobin)
__ Cuvettes/test tubes
___ Sahli/micropipette ___ Standard
__ Manual
___ Hematocrit Centrifuge
HEMATOCRIT ___ Hematocrit Reader
___ Capillary Tube
___ Sealer
1
DIFFERENTIAL __ Hematology
Slides
COUNT __ Glasses
Staining Kit
___ Staining Oil immersion
___
___ Microscope
(Binocular Compound)
DOH-HFSRB-CLG-AT AnnexB2
Revision: 00
06/44/2021
Page 20of 6
EQUIPMENT /
SERVICES INSTRUMENT / REAGENT/S REMARKS
.
Diluents
__
__Lyse
__ Cleanse
Other
Solution
Reagents
COMPLETE BLOOD
COUNT
__ Automated _.
___ Hematology Analyzer
Controls
___ Low
___ Normal
High
GROUPING AND Rh
(D) TYPING (Tube __ Semi-automated machine reagents
Blood Typing
;
M ethod) ___
Sera
__ Automated
Clinical Chemistry
__ Refrigerator (sample and
reagents)
Clinical Centrifuge __ Distilled Water
__ Standard/
__ Water Bath
or
its equivalent Calibrator
__— omer,
RBS /OGTT) Other Pipettes __ Pathologic
Total Cholesterol
Triglycerides
HDL. y
Luvelles
TestReagents
__ Test Tubes
Blood Uric Acid __ Test Tubes Rack — Total Cholesterol
Blood Creatinine
__ Triglycerides
Blood Urea __ HDL
Nitrogen
___ Manual
Spectrophotometer or its
__
Uric Acid
-
— Creatinine
equivalent
DOH-HFSRB-CLG-AT AnnexB2
Revision: 00
06/11/2021
Page 3 of 6
SERVICES
EQUIPMENT
INSTRUMENT /
GLASSWARE/SUPPLIES
.
/ (Te
REAGENT/S
Note
Take Note ofExim)
Expl
of
REMARKS
(Quality
Quality | Improvement)t
___
Test Reagents
—
a
AST
ALT
— AST
_ALT
Additional Services for Tertiary Category
Other Clinical ___Standard/
Chemistry Calibrator
Examinations — Manual
Controls
ARTERIAL BLOOD
__ Automated Analyzer — Potharogic
GASES (ABG) — for {indicate the name
of machine)
hospital-based
__ Test Reagents
Immunology / Serology
__ Cuvettes
__ Test Tubes
__ Test Tubes Rack __ Standard/
pi
if
Glass Pipettes Calibrator,
; applicable
pp
— Pipettes Pipette tips
:
&
BASIC SEROLOGIC
TESTING using
Rapid Test Kits — __ Rapid test kits
, . Controls, if
aoplicable
Pp
i” B,
Dengue, Hepatitis — Dengue
.
Syphilis, HIV ___ Syphilis
Hepatitis B (screening)
__ Normal
raed
— Pathologi
__ Test Reagents, if
HIV (screening)
—
applicable
__ Microscope or agglutination
viewer
Additional Services for Tertiary Category
Distilled Water
__
__ Standard/
Calibrator
__ Automated Analyzer
MACHINE-BASED (Indicate the of machine)
name Controls
SEROLOGICAL Normal
AND —_ Pathologic
IMMUNOLOGICAL — Manual
TESTING __Spectrophotometer or its
equivalent Test Reagents
__ Tumor Markers
___ Thyroid Function
Hepatitis Profile
ri
___
Microbiology
__ Microscope
(Binocular Compound)
__ Staining Rack
EARfor
TB DIRECT or Electric
Sod
Timer
__ Slides
__ Cover Slips
Inoculating Loops 2
DOH-HFSRB-CLG-AT AnnexB2
Revision: 00
06/11/2021
Page 4 of 6
EQUIPMENT /
SERVICES INSTRUMENT / REAGENT/S REMARKS
,
__ Applicator Sticks
__ Forceps
NUCLEIC ACID
AMPLIFICATION
Tha kits for
.
__ Autoclave
__ Weighing Scale
__MHA
__SFB _ TSBAPW
__ Water Bath __TCBS
__ Table Lamp ___Thio broth
__ Electric/Gas Stove
__ Refrigerator with freezer
_ MHA w/ 5%
sheep Blood
__ Microscope
(Binocular Compound)
__ Timer
PAP SMEAR __ Slides __ Papanicolaou
__ Cover Slips stain
__ Adhesive its equivalent
or
__ Forceps
0)
__ Staining Glasses
DOH-HFSRB-CLG-AT AnnexB2
Revision: 00
06/11/2021
Page 50f 6
EES
PATHOLOGY
CYTOLOGY
FROZEN SECTION,
if applicable
|
Additional Services for Tertiary Category
SURGICAL
~ Paraffin
- Microtome
Srosammatic
___
__
__
__
Oven
Cryostat
gs
EQUIPMENT /
__ Manual Technique
__ Water Bath
ontissue
Block holder
Ruler
Autopsy Table
Bone Saw
—
Toriatom
Formalin
___
Paraffin wax
Xylene
__ Chloroform
— Benzene
— loluene
___Carbon
tetrachloride
Hematoxylin
Eosin Stain
__Alcohol (50%,
80% 90%, 100%)
__Isopentane
Foe ematoxylin
Alcohol
(70%, 80%, 90%)
&
70%,
&
cameron
AUTOPSY, if __ Scalpel
applicable __ Scissors
Rib Shears
__
Toothed Forceps
__
__ Weighing Scale
Molecular Pathology
__ Water
Distilled
Indicate Services __Standard/
___
Clinical Centrifuge Calibrator
__ Refrigerator
Controls
__PCR __ Normal
___
Other Machines/Equipment/ __ Pathologic
Supplies
Test Reagents
"J
Note: These are the list of minimum requirements as to equipment, reagents/culture media,
supplies & glassware’s. Additional services are acceptable provided that appropriate items
mentioned with technical procedures, spa rsonnel are available, if necessary. (Please
use additional sheet of paper, if needed.)
DOH-HFSRB-CLG-AT AnnexB2
Revision: 00
et 6of6
44/2021